Plug for bone tissue

ABSTRACT

A cylindrical plug to close a femoral opening drilled in a femur to receive an intramedullary cutting guide, to prevent bleeding from the opening after removal of the intramedullary cutting guide from the opening.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/624,519, filed Dec. 19, 2019, which is the U.S. national stageapplication of International Application PCT/CA2018/050950, filed Aug.2, 2018, which international application was published on Feb. 7, 2019,as International Publication WO 2019/023807 A1 in the English language.The International Application claims priority of U.S. Provisional PatentApplication No. 62/540,972 filed Aug. 3, 2017.

FIELD OF THE INVENTION

The present disclosure relates to a plug to seal a bone cavity and theuse of the plug to seal the cavity.

BACKGROUND

Total knee replacement (TKR) is a widespread surgery in westerncountries recommended for patients who experience severe destruction oftheir knee joint. In 2010, approximately 700,000 TKRs were performed inthe United States only. By 2030, it is projected that over 3.5 millionprocedures will be performed annually.

During the procedure, the femoral canal is opened by drilling a hole inthe femur using a mesh having a diameter generally between 8 and 12 mm.This femoral opening is subsequently used to position an intramedullarycutting guide as shown in FIGS. 1 a and 1 b . This cutting guide ensuresthe proper orientation and position of the cut of the femoral bone forsubsequent installation the femoral prosthesis component.

The femoral opening created during the procedure allows blood to flowfrom the femoral canal to the surgical area both during and after thesurgical procedure which in turn contributes to the formation ofhematomas in the knee joint. This contributes to pain and causes a dropin hemoglobin level which can lead to systemic complications, increasedrisks of infection and/or require blood transfusions.

Currently, in order to reduce the bleeding, some surgeons may attempt toseal the femoral opening by impacting small fragment of bone cut duringthe surgery to create a bone plug, as shown in FIG. 2 . Performing thisprocedure takes times and the cutting of bone fragments may damagesurgical gloves which in turn increases the risks of infection andcontamination. Furthermore, the bone plug being impacted into thefemoral hole may be subsequently dislodged and may cause mechanicalmotion issues in the knee joint. Finally, this technique, althoughreducing bleeding from the femoral canal, does not seal the femoralopening in such a way that bleeding is eliminated.

There is accordingly a need to provide a plug for the femoral canaldiscussed above that alleviates at least some of the problems of thebone plugs currently used.

SUMMARY

According to various aspects of the present disclosure, there isprovided a use of a substantially cylindrical plug to close a femoralopening drilled in a femur to receive an intramedullary cutting guide,to prevent bleeding from the opening after removal of the intramedullarycutting guide from the opening.

According to another aspect of the present disclosure, there is provideda use pf a drill to drill an opening in a femur; intramedullary cuttingguide configured for insertion into the femur; a substantiallycylindrical plug having a size selected according to a size of theopening to close the opening subsequent a removal for the intramedullarycutting guide from the opening.

According to a third aspect of the present disclosure, there is provideda method for performing a knee surgery, comprising the steps of drillinga femoral opening in the femur; positioning an intramedullary cuttingguide in the opening; cutting the femur; removing the intramedullarycutting guide from the opening; providing a substantially cylindricalplug selected according to a size of the opening in the femur; insertingthe plug in the femoral opening to close the opening and preventbleeding from the opening; and performing any additional step tocomplete the knee surgery.

According to a fourth aspect of the present disclosure, there isprovided a plug configured to seal a femoral opening drilled in a femurto position an intramedullary cutting guide, the plug including asubstantially cylindrical body for insertion into the opening to engagebone surrounding the opening in order to create a seal to prevent bloodloss through the opening.

According to a fifth aspect of the present disclosure, there is provideda kit comprising an intramedullary cutting guide including a memberconfigured for insertion in a femoral opening drilled in a femur toposition the intramedullary cutting guide, the kit including a plughaving a generally cylindrical body, the plug having a transversedimensions selected according to a transverse dimensions of the memberin order to create close the opening after removal of the member fromthe opening.

These and other aspects of the present disclosure will now becomeapparent to those of ordinary skill in the art upon review of thefollowing description of embodiments in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a shows an isometric view of a femur with a femoral opening (indotted lines) to be drilled.

FIG. 1 b shows an isometric view of an intramedullary cutting guidepositioned into the femoral opening.

FIG. 2 shows a bone plug as currently used to be impacted in the femoralopening of FIGS. 1 a and 1 b without preventing bleeding from thefemoral opening.

FIG. 3 shows an isometric view of a plug for a femoral opening inaccordance with one non-limiting embodiment.

FIG. 4 shows a femoral opening drilled in the femur prior to positioningan intramedullary cutting guide during a TKR surgery.

FIG. 5 shows the femoral opening of FIG. 4 being sealed by the plugafter the femur has been cut during a TKR surgery in accordance with onenon-limiting embodiment.

DETAILED DESCRIPTION

With reference to FIG. 1 there is provided a plug 100 according to anon-limiting embodiment of the present disclosure. The plug 100 may beof a screw type, consisting of a generally cylindrical body 102 having alower portion and higher portion and featuring a helical threadstructure 104 running at least in part alongside a periphery of thecylindrical body 102. The plug 100 may be of any other suitable type(i.e., not of a screw type) in other embodiments. The plug 100 isconfigured to be inserted inside a cavity in a bone, in thisnon-limiting embodiment via its lower portion.

The helical thread structure 104 may be configured to engage an internalwall of the cavity when the plug 100 is inserted inside the cavity andgenerally prevent any fluid communication between the anatomical regionsfacing the lower and higher portions of the cylindrical body 102,respectively, when inserted in the cavity. In this non-limitingembodiment, the cavity is a femoral opening drilled in the femur toposition an intramedullary cutting guide. The cavity may notably bedrilled during a TKR surgery. However, other cavities may be suitable inother embodiments and the plug 100 may be configured to be inserted in acavity during other surgical procedures such as, but not limited to, arevision of total knee prosthesis, a retrograde rodding of the femur andthe likes. The helical thread structure 104 may comprise a series ofparallel ridges 105 ₁-105 _(i) generally extending about a periphery ofthe cylindrical body 102. In this embodiment, the ridges 105 ₁-105 _(i)comprise a single helix that spirals about the periphery of thecylindrical body 102. In other embodiments, the ridges 105 ₁-105 _(i)may comprise separate, discrete parallel bands around the periphery ofthe plug 100. The helical thread structure 104 may have any othersuitable configuration in other embodiments. In yet further embodiments,the plug 100 may not comprise a helical thread structure 104, as furtherdisclosed below.

The plug 100 may comprise a chamfered edge 106 at the bottom portion ofthe cylindrical body 102, the chamfered edge 106 being configured tofacilitate entry and positioning of the plug 100 in the cavity. In otherembodiments, the chamfered edge 106 may be absent and/or the bottomportion of the cylindrical body 102 may comprise any suitable element tofacilitate entry and positioning of the plug 100 in the cavity.

The plug 100 may comprise a socket 108 in the upper portion of thecylindrical body 102 configured for facilitating insertion of the plug100 inside the cavity. In this non-limiting embodiment, the socket 108may be of a traditional hex type socket or a 12-point torx type socketor any other suitable type of socket that enables a user to impart arotational motion to the plug 100 inside the cavity. This contributes tothe insertion of the helical thread structure 104 inside the walls ofthe cavity. The plug 100 may be inserted inside the cavity in any othersuitable way (e.g., without imparting a rotational movement to the plug100) in other embodiments.

Once inserted inside the cavity, the plug 100 is configured to generallyprevent any fluid communication between the anatomical regions facingthe bottom and the higher portions of the cylindrical body 102. That is,where the cavity is a femoral opening drilled in the femur to positionan intramedullary cutting guide, the plug 100 is configured to generallyprevent bleeding from the femoral canal inside the region of the kneejoint. The plug 100 is also configured to be generally stable onceinserted in the cavity, such that the plug 100 generally does not movelaterally or vertically in the cavity and remains inside the cavity onceinserted. That is, where the cavity is a femoral opening drilled in thefemur to position an intramedullary cutting guide, the plug 100 isconfigured to generally remain in the femoral opening and to not bedislodged from the femoral opening.

The plug 100 has a diameter and a length generally configured to sealthe cavity, which may be a femoral opening drilled in the femur toposition an intramedullary cutting guide. In one non-limiting example,the cylindrical body 102 of the plug 100 may have a diameter comprisedbetween 6 and 15 mm and a length between 10 and 30 mm. The cylindricalbody 102 may have any other suitable diameter and/or length in otherembodiments. In one embodiment, the cylindrical body 102 may have adiameter selected based on a diameter of a drill bit used to drill thefemoral opening in the femur such that the cylindrical body has adiameter configured to ensure the stability of the plug 100 onceinserted in the cavity, such that the plug 100 generally does not movelaterally or vertically in the cavity and remains inside the cavity onceinserted.

The chamfered edge 106 may have any suitable angle and size. The helicalthread structure 104 may have any suitable dimension and configurationsuch as pitch, pitch diameter and angle of the ridges 105 ₁-105 _(i).

In this non-limiting embodiment, the cylindrical body 102 is generallynot hollow. In other non-limiting embodiments, the cylindrical body 102may be generally hollow and configured to be inflated or mechanicallydeformed in order to make the plug 100 engage the cavity when the plug100 is inserted in the cavity and generally prevent any fluidcommunication between the bottom portion and a higher portion of thecylindrical body 102 when inserted in the cavity. In this embodiment,the cylindrical body 102 may be configured to retain its inflated ormechanically deformed shape after being inflated or mechanicallydeformed. It is appreciated that in the configuration where thecylindrical body 102 may be generally hollow and inflatable ormechanically deformable, the plug 100 may not comprise a helical threadstructure 104 and may not be inserted via a rotational motion to theplug 100 inside the cavity.

In this non-limiting embodiment, the plug 100 may be made of a metallicbiocompatible material, such as a titanium or stainless steel alloy. Theplug 100 may be made of any other suitable biocompatible material,metallic or non-metallic, in other embodiments. The plug 100 may also bemade of a non-biological material such that the plug 100 is not made ofbone tissue or any other bodily tissue. In other non-limitingembodiments, the plug may be made of any suitable biodegradablematerial.

The plug 100 may be a permanent plug. That is, the plug 100 may beconfigured to remain in the cavity. In other non-limiting embodiments,the plug 100 may be temporary, notably when the plug 100 is made of abiodegradable material.

In a non-limiting embodiment, the plug 100 may be used to seal a femoralopening drilled in the femur to position an intramedullary cuttingguide. This may notably be the case during a TKR surgery. In otherembodiments, the plug 100 may be used to seal a cavity in a bone duringother surgical procedures such as, but not limited to, a revision oftotal knee prosthesis, a retrograde rodding of the femur and the likes.

With reference to FIG. 4 , a step of TKR surgery is shown in which afemoral opening 400 has been drilled in the femur 402. The femoralopening is used at a subsequent step (not shown) to position anintramedullary cutting guide. The intramedullary cutting guide is thenused to cut the femur 402 (not shown).

With further reference to FIG. 5 , the cut portion 500 of the femur 402is shown after the intramedullary cutting guide has been removed andwith the plug 100 sealing the femoral opening 400, the plug 100generally preventing bleeding from the femoral canal inside the regionof the knee joint. It is appreciated that the femoral opening 400 issealed with a minimum of handling required from the operating surgeon.

Certain additional elements that may be needed for operation of someembodiments have not been described or illustrated as they are assumedto be within the purview of those of ordinary skill in the art.Moreover, certain embodiments may be free of, may lack and/or mayfunction without any element that is not specifically disclosed herein.

Any feature of any embodiment discussed herein may be combined with anyfeature of any other embodiment discussed herein in some examples ofimplementation.

In case of any discrepancy, inconsistency, or other difference betweenterms used herein and terms used in any document incorporated byreference herein, meanings of the terms used herein are to prevail andbe used.

Although various embodiments and examples have been presented, this wasfor the purpose of describing, but not limiting, the present disclosure.Various modifications and enhancements will become apparent to those ofordinary skill in the art and are within the scope of the invention,which is defined by the appended claims.

1. A femoral plug for sealing a femoral opening drilled in a distalregion of a femur forming part of a knee joint to receive anintramedullary rod of an intramedullary cutting guide therein, thefemoral plug comprising: an elongated body sized for insertion into thefemoral opening, the elongated body being free of a through hole; andthreads extending around at least a portion of the elongated body toengage bone surrounding the femoral opening to form a seal with the boneto prevent blood loss from the femoral opening into the knee joint. 2.The femoral plug of claim 1, wherein the threads comprise a helicalthread structure.
 3. The femoral plug of claim 2, wherein the helicalthread structure comprises a series of parallel ridges.
 4. The femoralplug of claim 3, wherein the parallel ridges comprise a single helixthat spirals about a periphery of the elongated body.
 5. The femoralplug of claim 3, wherein the parallel ridges comprise discrete parallelbands around a periphery of the elongated body.
 6. The femoral plug ofclaim 1, wherein the elongated body comprises a chamfered edge tofacilitate entry of the femoral plug into the femoral opening.
 7. Thefemoral plug of claim 1, further comprising a socket to aid in insertionof the femoral plug into the femoral opening.
 8. The femoral plug ofclaim 1, further comprising a tool-engaging portion configured to beengaged by a tool for driving the femoral plug into the femoral opening.9. The femoral plug of claim 1, wherein the femoral plug is made of abiodegradable material.
 10. The femoral plug of claim 1, wherein theelongated body is a substantially cylindrical body.
 11. The femoral plugof claim 1, wherein the femoral plug has a femoral plug diameter that isselected based on a diameter of a drill bit used to drill the femoralopening in the distal region of the femur.
 12. A femoral plug forsealing a femoral opening drilled in a distal region of a femur formingpart of a knee joint to receive an intramedullary rod of anintramedullary cutting guide therein, the femoral plug comprising: amonolithic elongated body sized for insertion into the femoral opening,the monolithic elongated body being configured to fill substantially anentire cross-sectional area of the femoral opening; and threadsextending around at least a portion of the monolithic elongated body toengage bone surrounding the femoral opening to form a seal with thebone; wherein the femoral plug is configured to prevent blood loss fromthe femoral opening into the knee joint.
 13. The femoral plug of claim12, wherein the threads are integrally formed with the monolithicelongated body.
 14. The femoral plug of claim 12, wherein the monolithicelongated body is a substantially cylindrical body.
 15. The femoral plugof claim 12, wherein the threads comprise a helical thread structure.16. The femoral plug of claim 15, wherein the helical thread structurecomprises a series of parallel ridges.
 17. The femoral plug of claim 16,wherein the parallel ridges comprise a single helix that spirals about aperiphery of the monolithic elongated body.
 18. The femoral plug ofclaim 16, wherein the parallel ridges comprise discrete parallel bandsaround a periphery of the monolithic elongated body.
 19. The femoralplug of claim 12, wherein the monolithic elongated body comprises achamfered edge to facilitate entry of the femoral plug into the femoralopening.
 20. The femoral plug of claim 12, further comprising atool-engaging portion configured to be engaged by a tool for driving thefemoral plug into the femoral opening.